510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2136 of 3531

510(k) clearances, page 2136 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941564	Immulite Alatop Allergy Screen	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1994-12-19
K940767	Orex (12X12 X-Ray Detectable)	Thantex Specialties, Inc.	GDY	Class I	1994-12-19
K940766	Orex (18X18 X-Ray Detectable)	Thantex Specialties, Inc.	GDY	Class I	1994-12-19
K940765	Isolyser	Thantex Specialties, Inc.	EFQ	Unclassified	1994-12-19
K940764	Orex	Thantex Specialties, Inc.	GDY	Class I	1994-12-19
K940716	Orex	Thantex Specialties, Inc.	EFQ	Unclassified	1994-12-19
K940006	Immulite Third Generation (Modification)	Siemens Healthcare Diagnostics Inc.	JLW	Class II	1994-12-19
K935399	Radias Neonatal Tsh Enzyme Immunoassay	Bio-Rad	JLW	Class II	1994-12-19
K933805	Ring Electrode	Cadwell Laboratories, Inc.	GXY	Class II	1994-12-19
K933716	Abbott Chagas Antibody Eia	Abbott Medical	MIU	Class I	1994-12-19
K933212	Immulite Rapid Tsh	Siemens Healthcare Diagnostics Inc.	JLW	Class II	1994-12-19
K932989	Coat-a-Count Free Estriol	Siemens Healthcare Diagnostics Inc.	CGI	Class I	1994-12-19
K931059	Imx Rubella Igm Antibody Assay	Abbott Medical	LFX	Class II	1994-12-19
K945970	Insufflator Filter Tubing Set	Xylog Corp.	FCX	Class II	1994-12-15
K945770	Optical Frames	Ramada Optics, Inc.	HQZ	Class I	1994-12-15
K945751	Karl Storz Trocard, Flexible Trocar Sleeves	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-12-15
K945563	Convertible Contact Side-Firing Refractive Fiber (C-Srf(tm))	Energy Life Systems Corp.	GEX	Class II	1994-12-15
K945392	Spectacle Frame	Seo Han Corp., Ltd.	HQZ	Class I	1994-12-15
K945238	Mavig Lower Body Protection Systems, Assembly Models 6265, 6266, 6267, 6268, 6269/0, 629/1, and 6269/2	F. Walter Hanel GmbH	IWQ	Class I	1994-12-15
K945176	Spectacle Frame or Eyeglass Frames	Optipia Trading Co.	HQZ	Class I	1994-12-15
K945173	Pulpdent Hardshell	Pulpdent Corporation	EBF	Class II	1994-12-15
K944880	Bodily Fluid Disposal Kit	Clinical Resources, Inc.	FXX	Class II	1994-12-15
K944876	Human Igg Subclasses Nephelometric Bna Kit	Research Diagnostics, Inc.	DAS	Class I	1994-12-15
K944857	Goggle Safeguard	Sellstrom Mfg. Co.	HOY	Class I	1994-12-15
K944845	Ortholoc Advantim Modular Femoral Augment Component	Wrightmedicaltechnologyinc	JWH	Class II	1994-12-15
K944603	Conmed Versa Stem Neuromuscular Stimulation/tens	Conmedcorp	GXY	Class II	1994-12-15
K944575	Aquafresh Plaque Fighting Gum	Smithkline Beecham Consumer Healthcare Products	EJR	Class I	1994-12-15
K944523	Humphrey Oct (Optical Coherence Tomography) Scanner	Humphrey, Inc.	IYO	Class II	1994-12-15
K944474	Optilite V Fiberoptic Accessories	Xintec Corporation	GEX	Class II	1994-12-15
K944421	E.coli 0157 Latex Test	Pro-Lab Diagnostics	GMZ	Class I	1994-12-15
K944398	Sunglasses	Sun Island Enterprise Co., Ltd.	HQY	Class I	1994-12-15
K944319	Biomic Microbiology Data Management System	Giles Scientific Inc	KZK	Class I	1994-12-15
K944300	Karl Storz Insulated Biopsy Forceps	Karl Storz Endoscopy-America, Inc.	KNF	Class II	1994-12-15
K944297	Karl Storz Insulated Scissors	Karl Storz Endoscopy-America, Inc.	KNF	Class II	1994-12-15
K944235	Advance Corp. Sunglasses	Advance Corp.	HQY	Class I	1994-12-15
K944221	Verruca-Freeze(tm) Cryosurgical Delivery Syst, Modified	Cryosurgery, Inc.	GEH	Class II	1994-12-15
K944139	Dental Hygiene Tray	Sterile Concepts, Inc.	LYY	Class I	1994-12-15
K943589	Stryker Total Performance System	Stryker Corp.	HWE	Class I	1994-12-15
K943476	Gip/medi-Globe Goreign Body Graspers	Medi-Globe GmbH	OCZ	Class II	1994-12-15
K943415	Merit (O.1t Mr System)	Philips North America LLC	LNH	Class II	1994-12-15
K943406	RF Driver, Radio Frequency Driver	Pro-Comm, Inc.	IYE	Class II	1994-12-15
K943268	Scs-1000 (Sysmex Calibrator System)	Streck Laboratories, Inc.	KSA	Class II	1994-12-15
K943256	Cardiac Output Option 39	Medical Data Electronics	DXG	Class II	1994-12-15
K942902	Sharps-Tainer Small Opening W/needle Remover	Winfield Co., Inc.	MMK	Class II	1994-12-15
K942787	Bone Anchor	Acu Med, Inc.	JDR	Class II	1994-12-15
K942743	Viro Varicella-Zoster Virus Identification Reagent	Viro Research LLC	GQW	Class II	1994-12-15
K942447	Hasson Open Laparoscopy Cannula	Linvatec Corporation	HET	Class II	1994-12-15
K941838	Multiple CO2 Laers	Mattioli Engineering Corp.	GEX	Class II	1994-12-15
K941425	Alamar Antibiotic Susceptibility	Alamar Biosciences Laboratory, Inc.	LRG	Class II	1994-12-15
K941162	Hypergraph	Dermed Diagnostics, Inc.	DSB	Class II	1994-12-15